FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SURGITEK FLAT T-SPAN
K Number: K884746
·
Decision Aug 10, 1989
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
28
Review Days
269
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Basic Information
- Device Name
- SURGITEK FLAT T-SPAN
- K Number
- K884746
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Medical Engineering Corp.
- Date Received
- November 14, 1988
- Decision Date
- August 10, 1989
- Product Code
- LCJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCJ), ordered by most recent decision date.
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FDA 510(k)
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MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
FDA 510(k)
FDA Unclassified
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Mentor CPX 4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR CPX4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934141 | STAND ALONE CYSTOMETROGRAM | Nov 18, 1993 | Substantially Equivalent |
| K905289 | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT | Mar 13, 1991 | Substantially Equivalent |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | Jan 14, 1991 | Substantially Equivalent |
| K902773 | SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET | Jul 16, 1990 | Substantially Equivalent |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Feb 8, 1989 | Substantially Equivalent |
| K881736 | SURGITEK CO2 DELIVERY SYSTEM | Aug 11, 1988 | Substantially Equivalent |
| K880802 | SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 | May 26, 1988 | Substantially Equivalent |
| K880801 | SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 | May 26, 1988 | Substantially Equivalent |
| K842748 | SURGITEK RECONSTRUC-NIPPLE PROSTHESIS | Sep 26, 1984 | Substantially Equivalent |
| K832043 | SURGIKEK PENILE PROSTHESIS TAIL EXTEND | Oct 20, 1983 | Substantially Equivalent |